The pharmaceutical giant expressed optimism that its new flu shot would be available this year, after approval concerns.<\/p>\n
Listen to this article\u00a0|\u00a03 mins<\/p>\n
info<\/p>\n
By Reuters and The Associated Press<\/p>\n
Published On 18 Feb 202618 Feb 2026<\/p>\n
Click here to share on social media<\/p>\n
share2<\/p>\n
The federal agency tasked with regulating drugs in the United States has said it will review a flu vaccine application from the pharmaceutical giant Moderna, one week after it declined to do so in an unusual move.<\/p>\n
Moderna announced on Wednesday that the Food and Drug Administration (FDA) had accepted a revised application seeking full approval for a new flu shot to be offered to patients between the ages of 50 and 64 and expedited approval for those over 65.<\/p>\n
Recommended Stories list of 3 itemsend of list<\/p>\n
\u201cPending FDA approval, we look forward to making our flu vaccine available later this year so that America\u2019s seniors have access to a new option to protect themselves against flu,\u201d CEO Stephane Bancel said in a statement.<\/p>\n
He also expressed thanks for the FDA\u2019s \u201cengagement\u201d on the issue.<\/p>\n
The FDA\u2019s decision to accept Moderna\u2019s application marked an abrupt reversal from its earlier stance. On February 10, Moderna revealed that the FDA had denied its application to review the new flu vaccine for use among older adults.<\/p>\n
That announcement sparked concerns in the pharmaceutical industry about how new vaccines would be received under US President Donald Trump, whose administration has rescinded certain vaccine guidelines.<\/p>\n
Some Trump officials, most notably Health and Human Services Secretary Robert F Kennedy Jr, have also spread false claims about vaccine safety.<\/p>\n
At the time, Moderna called the agency\u2019s rejection \u201cinconsistent with previous written communications\u201d with the FDA.<\/p>\n
The decision, Bancel said in a statement, \u201cdid not identify any safety or efficacy concerns with our product\u201d and \u201cdoes not further our shared goal of enhancing America\u2019s leadership in developing innovative medicines\u201d.<\/p>\n
The agency\u2019s refusal to consider the company\u2019s application was an unusual move.<\/p>\n
In a \u201crefusal to file\u201d letter rejecting the initial application, the FDA\u2019s vaccine director Vinay Prasad argued that Moderna should have included a high-dose brand for comparison in its trial process.<\/p>\n
Moderna had undertaken a 40,000-person clinical trial, focused on adults age 50 and older, that concluded its new vaccine was more effective than a standard shot.<\/p>\n
The company publicly responded that the FDA had itself recommended that approach when it approved the trial study.<\/p>\n
In a compromise, Moderna agreed to conduct another study once the new flu shot is available. The FDA is aiming to reach a decision on the revised application by August 5.<\/p>\n
The flu shot was created with mRNA technology, a subject of frequent criticism from Kennedy, who has promoted anti-vaccine views and replaced experts in the Health and Human Services Department with figures who share his scepticism.<\/p>\n
Last June, Kennedy cancelled nearly $500m in federal research grants and contracts for research into mRNA vaccines.<\/p>\n","protected":false},"excerpt":{"rendered":"The pharmaceutical giant expressed optimism that its new flu shot would be available this year, after approval concerns.…\n","protected":false},"author":2,"featured_media":476327,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[18],"tags":[23,12,2605,2420,97,3,9107,21,19,22,20,25,1209,24],"class_list":{"0":"post-476326","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-united-states","8":"tag-america","9":"tag-donald-trump","10":"tag-drugs","11":"tag-government","12":"tag-health","13":"tag-news","14":"tag-regulation","15":"tag-united-states","16":"tag-united-states-of-america","17":"tag-unitedstates","18":"tag-unitedstatesofamerica","19":"tag-us","20":"tag-us-canada","21":"tag-usa"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/476326","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=476326"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/476326\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/476327"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=476326"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=476326"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=476326"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}